Regional anesthesia for carotid endarterectomy surgery.
Conditions
Interventions
Trade Name: Naropin
Product Name: Ropivacain (Naropin)
Pharmaceutical Form: Injection
INN or Proposed INN: Ropivaca 7.5 mg/ml:1 ml solution for injection contains ropivacaine hydrochloride monohydrate
Sponsors
UK für Anästhesiologie und allgemeine Intensivmedizin, LKH Salzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with elective scheduled carotid endarterektomy surgery under regional anesthesia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: refusal to participate in the trail age < 18a gestation/breastfeeding contraindication for regional anesthesia inclusion in other trails
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study the Influence of the concentration of the local anesthetic ropivacaine on the quality of the cervical plexus block for carotid endarterectomy will be evaluated. For this purpose two different concentrations of Ropivacaine will be compared (3,75% vs 7,5%).;Secondary Objective: Not applicable;Primary end point(s): amount of additional needed local anesthetics by the surgeon ;Timepoint(s) of evaluation of this end point: during the whole surgical procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): incidence to change to general anesthesia incidence of side effects linked to the regional anesthesia additional need of analgesics/sedation plasma concentration of the used local anesthetics duration of the surgery clamping time of the carotid artery cerebral oxygenation incidence of temporary neurological side effects blood pressure heartbeat per minute spO2 incidence of carotid shunting incidence of cardiovascular events effect on the diaphragm function needed inspiratory oxygen fraction patient statisfaction ;Timepoint(s) of evaluation of this end point: continuously recorded during the whole surgical procedure, as well as until 10h after the procedure | — |
Countries
Austria
Contacts
Public ContactDr. Andreas Koköfer
Uk für Anästhesiologie, LKH Salzburg, SALK
Outcome results
None listed